Wire and pulley clock mechanism flow regulator

ABSTRACT

An automatic injection device with flow regulation. The automatic injection device has an insertion needle configured to be inserted into a patient and a drug container which contains a pharmaceutical product and includes a plunger. The automatic injection device also has a fluid path which fluidly connects the drug container to the patient via an insertion device, a potential energy source, and a regulator configured to restrict release of potential energy and restrict linear movement of the plunger and pharmaceutical product into the fluid path at a proscribed pace. The regulator includes a clock escapement mechanism and a wire and pulley system including a wire coupled to at least one pulley. The potential energy source may be a spring that surrounds the drug container and may be directly coupled to the plunger and the wire such that movement of the spring and the wire is restricted over time.

PRIORITY CLAIM

This application is a divisional of U.S. patent application Ser. No.16/006,196, filed on Jun. 12, 2018, which claims the benefit of U.S.Provisional Application No. 62/535,083, filed on Jul. 20, 2017, thecontents of which are incorporated by reference as if fully set forthherein.

SUMMARY

The present disclosure is directed to flow regulation of an automaticinjection device utilizing a wire and pulley clock mechanism. Theautomatic injection device includes an insertion needle configured to beinserted into a patient and a drug container which contains apharmaceutical product and includes a plunger. The automatic injectiondevice also includes a fluid path which fluidly connects the drugcontainer to the insertion needle, a potential energy source, and aregulator configured to cause a predefined, possibly linear movement ofthe plunger to force the pharmaceutical product into the fluid path at aproscribed pace. The potential energy source may be a spring containedinside the drug container and may be directly coupled to the back of theplunger. The clock escapement mechanism applies a counterforce and thusrestricts movement of the spring and plunger in a controlled rate over aspecified time interval, using a gearbox and a wire and pulley systemdirectly attached to the spring.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view illustration of an exemplary automatic injectiondevice positioned on a patient;

FIG. 2 is a schematic illustration of the components of an automaticinjection device consistent with disclosed embodiments;

FIG. 3 is a perspective view of a top side of the automatic injectiondevice;

FIG. 4 is a perspective view of a bottom side of the automatic injectiondevice;

FIG. 5 is a perspective view of the internal components according to anembodiment of the automatic injection device;

FIG. 6 is a perspective view of the internal components of a clock,incorporated in an embodiment of the clock escapement mechanism for theregulator.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Injection devices are used to deliver pharmaceutical products such asbiologics and medications to a patient (i.e., a person or animal). Asyringe and needle is an example of a widely-used injection device. Thisbasic system typically involves a person manually moving a plungerportion of the syringe to force the pharmaceutical product through theneedle and into the patient. Other injection devices have been developedto deliver pharmaceutical products automatically at the touch of abutton or the actuation of a switch. These devices are advantageous inthat they allow a patient to more easily self-administer thepharmaceutical product. Moreover, some automatic injection devices allowfor slow or periodic delivery of the pharmaceutical product as needed,which is a typical procedure for patients dependent on insulininjections, for example. However, there is a need for automaticinjection devices to provide increased injection control in a compactdevice such that the device is easy to handle and discrete for a patientwho may wear the device for an extended period of time.

Disclosed embodiments pertain to a regulator for an automatic injectiondevice. For example, the regulator may be configured to control movementof a plunger placed in a drug container. Further movement of the plungerinside the drug container pushes the pharmaceutical product through afluid path and to an insertion needle which connects to the patient.This controlled movement of the plunger allows for metered delivery ofthe pharmaceutical product according to desired parameters.

The disclosed regulator includes features which allow for precisecontrol over plunger movement which is based on stored potential energywhile providing a small form factor which allows the automatic injectiondevice to be compact. The disclosed regulator utilizes a clockescapement mechanism and a potential energy source in order to controlmovement of the plunger. In the embodiment set forth in the drawings andas described hereinafter, the potential energy source is a spring thatmay directly push the connected plunger; but that is just by way ofexample. In other embodiments, any potential energy source may beutilized, including compressed air.

Current energy sources for automatic injection devices utilize springsas an energy source for pumping the pharmaceutical product out of thedevice and into a patient. These springs, however, apply a variableforce because the force of the spring is relative to its displacement.This varies the velocity and rate of infusion.

In contrast, the described embodiments regulate potential energy in aproscribed regulated pace. In the embodiment set forth in the drawingsand as described hereinafter, the disclosed regulator includes amechanical clock escapement mechanism utilizing a wire and pulley systemthat restricts movement of the spring over a specified period of timefor more restricted and controlled release. Thus, the clock escapementmechanism controls the plunger so that the velocity of the potentialenergy source and rate of infusion is constant. This configurationallows for a cost-effective, space saving alternative to control themovement of the plunger with a passive, mechanical driving device. Thisconfiguration, when totally mechanical, can undergo sterilizationprocedures that a unit with electronics may not be able to utilize.

It should be understood that other types of regulators may be used inplace of a clock mechanism, and one of skill in the art may utilizeother mechanical mechanisms in order to restrict and regulate themovement of the plunger. In some embodiments, the clock escapementmechanism may be connected to a device which further regulates thespring over a specified time interval. This restriction of movement ofthe spring may restrict movement of the plunger and thus movement of thepharmaceutical product out of the drug container over time (e.g., andinto a patient through a fluid path).

FIG. 1 is a depiction of an exemplary embodiment of an automaticinjection device 12 on a patient 10. The patient 10 is not limited andcan be any organism which may receive an injection. The device 12 isconfigured to deliver a pharmaceutical product to the patient 10automatically. This means that the device 12 is controlling theinjection in some way such that the system differs from other injectionsystems where manual input alone causes the injection (i.e., aconventional syringe and needle system or other available systems). Theautomatic aspect of the device 12 may additionally or alternativelyrelate to the duration of the injection, controlled injection intervals,a delay between input and injection, etc.

The device 12 includes a base 14 that contacts the patient's skin. Thedevice 12 includes an insertion needle 16 which enters a patient todeliver a pharmaceutical product, such as insulin, to the patient. Anexample of an automatic injection device which includes many of thefeatures that may be incorporated into the device 12 is described in WO2017/007952, which is herein incorporated by reference. However, itshould be understood that the device 12 is not limited to the automaticinjection device described therein or the exemplary embodimentsdescribed below. An automatic injection device consistent with thisdisclosure may include some of the features described herein but is notlimited thereto. For example, a disclosed automatic injection device mayresemble a syringe and needle system or other injection system, which isadapted for automatic injections via the features described herein.

FIG. 2 is a schematic illustration of the automatic injection device 12and flow regulator 24 and the basic features of the device 12 whichfacilitate automatic injections of a pharmaceutical product into thepatient 10. The device 12 preferably includes a housing 18 which holdsat least some of the features of the device 12. In addition to theinsertion needle 16, these features preferably include a drug container20, a fluid path 22, a regulator 24 and potential energy source 26.These features work in conjunction with each other to automatically andmechanically deliver a pharmaceutical product to the patient 10according to desired parameters.

The regulator 24 provides the automatic aspect of the injections viadevice 12. For example, the regulator 24 is a mechanical system whichrestricts movement of the pharmaceutical product from the drug container20 to the fluid path 22 and ultimately into the patient 10 at aproscribed pace. In the embodiment described in the drawings andhereinafter, the regulator 24 mechanically regulates movement of aplunger (not depicted). In other embodiments, the regulator 24 mayinclude both a mechanical unit and a small electrical unit that mayexert a minimal amount of energy for regulating movement of the plungerand release of the fluid at a proscribed pace. For example, in oneembodiment, the regulator 24 may include a ratchet mechanism thatreleases potential energy from the potential energy source at a certainpace and exerts a small fraction of energy in order to stop themechanism in a required pace. The ratchet may be stopped and released bya small electrical unit such as a solenoid or a different actuator. Inaddition, in another embodiment, the regulator may control the flowbetween the needle and the fluid path by periodically obstructing fluidflow.

The drug container 20 is a containing element which supplies thepharmaceutical product. The drug container 20 may be a vial, syringe, orthe like and includes a space for containing the pharmaceutical product,which is not limited to a particular substance. The pharmaceuticalproduct may be any substance which is considered one or more of a drug,biologic, medication, or placebo, for example. The drug container 20 ispreferably a hollow cylindrical tube which receives the pharmaceuticalproduct. However, it should be understood that other configurations arepossible.

In the device 12, the drug container 20 is fluidly connected to theinsertion needle 16 by the fluid path 22. The fluid path 22 may be aphysical connecting channel which serves as a conduit for delivering thepharmaceutical product from the drug container 20 to the insertionneedle 16 and ultimately into the patient 10. The fluid path 22 mayinclude additional structure, including actuating mechanisms whichinitiate delivery of the pharmaceutical product and/or controlmechanisms which meter an amount of product which is delivered to thepatient 10 at any particular time. The fluid path 22 may include anelement or mechanism which is configured to establish the connectingchannel, such as a puncturing needle or the like. The fluid path 22 maybe associated with a mechanical start button or control switch whichcontrol an element of the fluid path 22 (e.g., a valve) in order tostart or stop the delivery of the pharmaceutical product. It should beunderstood, however, that the fluid path 22 may be a passive systemcomponent in at least some embodiments.

FIGS. 3 and 4 further illustrate an exemplary embodiment of theautomatic injection device 12. FIG. 3 illustrates a first side of thedevice 12, including the housing 18 which rests on top of the base 14.The housing 18 is illustrated as being rectangular, but can include anyshape. The housing 18 may include optional features such as a window 30which provides a view of the drug container 20 and thus the currentfluid level.

FIG. 4 illustrates a second side of the device 12 including a bottomsurface of the base 14. The bottom surface 32 includes an opening 34 forreceiving the insertion needle 16. In use, the device 12 is placedagainst the patient 10 with the bottom surface 32 of the base 14 againstthe skin. An injection needle extends through the opening 34 and intothe patient 10 to deliver the pharmaceutical product. The bottom surface32 may include an adhesive material thereon to adhere the device 12 tothe patient 10 for either a short or long period of time, depending onthe particular use of the device 12.

FIG. 5 illustrates the device 12 incorporating the flow regulator 24having a wire and pulley system with the top portion of the housing 18removed such that the internal features are shown in an enclosed space36 formed by a lower portion of the housing 18 and the base 14. Thedevice 12 includes exemplary embodiments of the insertion needle 16, thedrug container 20, the fluid path 22, and the regulator 24. The enclosedspace 36 houses at least the drug container 20 and the regulator 24 suchthat the elements are positioned inside of the housing 18.

The fluid path 22 in this embodiment includes a connector 38 whichphysically connects to the drug container 20 to establish a connectionchannel between the interior of the drug container 20 and the insertionneedle 16. In the illustrated embodiment, the insertion needle 16 ispositioned perpendicular to the drug container 20 such that the path ofthe pharmaceutical product is to travel out of the drug container 20 andlaterally into the area of the insertion needle 16 via the fluid path22. The pharmaceutical product subsequently travels vertically downwardthrough the insertion needle 16 and into the patient 10. Thisconfiguration is exemplary, however, and the disclosed embodiments arenot limited thereto. In other embodiments, the insertion needle 16 maybe aligned in the same direction as the drug container 20 and/or thefluid path 22.

In the present embodiment, the regulator 24 includes a clock escapementmechanism 40 and a pulley system 54 that includes a wire 54A. The clockescapement mechanism 40 includes a set of gears 40A coupled to thepulley system 54. In one embodiment, the clock escapement mechanism 40inhibits movement of the spring 44 via the gears 40A and the wire 54Aand the pulley system 54, by applying a counterforce to the spring 44.The wire 54A of the pulley system 54 may be coupled to a set of pulleys54B and connected to the spring 44 itself. The movement of the wire 54Aand the pulley system 54 controls and restricts movement of the spring44 inside the drug container 20, which controls and restricts movementof the plunger 50 in a linear motion inside the drug container 20.

In the embodiments set forth in the drawings and described hereinafter,the spring 44 is positioned inside of the drug container 20 and isconnected to the plunger 50 directly, but this is just by way ofexample. The direct connection between the spring 44 and the plunger 50may move the spring 44 and thus the plunger 50 forward at a controlledproscribed pace during release of the pharmaceutical product. The spring44 may be positioned behind the drug container 20 and connected to theplunger 50, such that the spring 44 pushes the plunger 50 during releaseof the pharmaceutical product.

FIG. 5 depicts the spring in a resting position, as fluid stored in thedrug container 20 is completely released into the fluid path 22. Theclock escapement mechanism 40 is configured to slowly allow the spring44 to move between settings to the resting positions over a specifiedtime interval via the wire 54A and the pulley system 54. The wire 54Aand the pulley system 54 may be coupled to the spring at a firstlongitudinal end 46 of the drug container 20. As a result, movement ofthe wire 54A along the pulley 54B moves the spring 44.

When fluid is stored in the drug container 20, the spring 44 is woundand stored potentially energy increases until release of the fluid intothe fluid path 22 during injection via the plunger 50. During injection,the clock escapement mechanism 40 restricts movement of the wire 54A andthe pulley system 54. The wire 54A and the pulley system 54 thusrestricts unwinding of the spring 44 at a controlled pace. In theprocess of unwinding and returning to a resting position, the spring 44pushes the plunger 50 incrementally as controlled by the wire 54A of thepulley system 54, toward a second longitudinal end 48 of the drugcontainer 20, thereby forcing the pharmaceutical product into the fluidpath 22 and ultimately delivering it to the patient 10 through theinsertion needle 16 in a controlled manner over the specified timeinterval, as needed. Other mechanisms may be utilized in order tocontrol movement of the plunger 50 if the spring 44 is not directlyconnected to the plunger 50. It should be noted that in otherembodiments, other mechanisms for connecting the spring 44 and theplunger 50 to control movement may also be utilized.

FIG. 6 is a perspective view of the internal components of a clockincorporated in an embodiment of the clock escapement mechanism 40 forthe regulator 24. Components of the escapement mechanism of the clockmay be similar to the clock escapement mechanism 78, which includes anescape wheel 78A and a pallet 78B. In the present embodiment, the clockescapement mechanism 78 further regulates the periodic movement of thegear 40A, 40C (not depicted), while, the balance wheel 74 is operativelycoupled to the escapement mechanism 78 via the pallet 78B.

When the spring 44 begins to move, the escapement mechanism 78, thebalance wheel 74, and the gear 40A begin to move. As the balance wheel74 moves rotationally, clockwise and counterclockwise periodically, themovement releases a tooth of the escape wheel 78A of the escapementmechanism 78. The release of the tooth of the escape wheel 78A allowsthe gear 40A (not depicted) to only advance by a fixed amount. Thisregular periodic advancement moves the gear 40A in a controlled andrestricted manner. This control also restricts movement of the wire 54Aand the pulley system 54 (not depicted), which further restrictsmovement of the spring 44 (not depicted) over a time interval. Thisconfiguration enables delivery of the pharmaceutical product at a morecontrolled rate over a specified time.

Having thus described the presently preferred embodiments in detail, itis to be appreciated and will be apparent to those skilled in the artthat many physical changes, only a few of which are exemplified in thedetailed description of the invention, could be made without alteringthe inventive concepts and principles embodied therein. It is also to beappreciated that numerous embodiments incorporating only part of thepreferred embodiment are possible which do not alter, with respect tothose parts, the inventive concepts and principles embodied therein. Thepresent embodiments and optional configurations are therefore to beconsidered in all respects as exemplary and/or illustrative and notrestrictive, the scope of the invention being indicated by the appendedclaims rather than by the foregoing description, and all alternateembodiments and changes to this embodiment which come within the meaningand range of equivalency of said claims are therefore to be embracedtherein.

What is claimed is:
 1. A flow regulator for an injection device,comprising: a clock escapement mechanism comprising a pallet and anescape wheel gear, and further including a balance wheel, a gearboxcomprising at least one set of gears coupled to the clock escapementmechanism, and a wire coupled to at least one pulley and further coupledto the gearbox and to a potential energy source of the injection device;wherein the clock escapement mechanism is configured to restrictmovement of the wire and restrict release of potential energy from thepotential energy source over a proscribed period of time.
 2. The flowregulator of claim 1, wherein the potential energy source comprises aspring configured to move a plunger in the injection device.
 3. The flowregulator of claim 1, wherein the wire and the at least one pulley isconfigured to resist movement of the potential energy source and convertrotational movement of the gearbox into a linear motion.
 4. The flowregulator of claim 1, wherein the escape wheel gear is configured torestrict the release of potential energy from the potential energysource over a time interval.
 5. The flow regulator of claim 2, whereinthe wire is directly coupled to the spring at a first longitudinal endof the injection device.
 6. The flow regulator of claim 5, wherein thespring pushes the plunger toward a second longitudinal end of theinjection device.
 7. The flow regulator of claim 6, wherein the springis directly connected to the plunger.
 8. The flow regulator of claim 6,wherein the clock escapement mechanism applies a counterforce to thespring to restrict release of the potential energy from the spring overthe proscribed period of time.
 9. The flow regulator of claim 8, whereinthe at least one set of gears is configured to move upon movement of thespring.
 10. The flow regulator of claim 1, wherein the wire and the atleast one pulley are configured to resist movement generated by thepotential energy source and convert rotational movement of the at leastone set of gears into a linear motion.
 11. The flow regulator of claim1, further comprising an electric circuit that measures time andcontrols release of the potential energy from the potential energysource over the proscribed period of time.